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The protocol was written in accordance with SPIRIT guidelines\u00a0(Additional file ). Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. Written informed consent will be obtained from all subjects by the clinical research team prior to enrollment and any study-related procedures. Additional consent will be obtained for the collection and use of optional skin biopsies. Subjects will be given sufficient opportunity to consider participation in this study before signing the consent form. Study participation is voluntary and can be withdrawn at any time. This study will be conducted in accordance with the Declaration of Helsinki, ICH GCP, and applicable regulatory requirements.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"432"}}